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Cuvposa Approval History

FDA Approved: Yes (First approved July 28, 2010)
Brand name: Cuvposa
Generic name: glycopyrrolate
Dosage form: Oral Solution
Company: Shionogi Pharma Inc.
Treatment for: Chronic Drooling in Children

Cuvposa (glycopyrrolate) oral solution is an anticholinergic for the treatment of chronic severe drooling caused by neurologic disorders in children.

Development History and FDA Approval Process for Cuvposa

DateArticle
Jul 29, 2010Approval FDA Approves Cuvposa for Chronic Drooling in Children
Sep 29, 2009Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

Further information

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